NCT01734616

Brief Summary

With age, muscles tend to waste at 0.5-1% per year, so that an 80 year old may have only 70% of the muscle possessed at 50. Muscle loss makes it harder to carry out tasks that require strength, keep the body balanced and continue activity for a prolonged period, which together may contribute to a loss of independence and an increased risk of falls. The cause of some of this muscle loss with ageing appears to be a reduction in muscle building in response to food. The known decreased limb blood flow in ageing muscle may go some way to explain this as there may be less nutrient delivery to the muscles. The investigators want to test if the known decrease in limb blood flow with age is matched with a decrease in the proportion of blood being delivered directly to the muscles, rather than fat and connective tissue. If so the investigators expect to see an improvement in the ability of muscles to maintain themselves via better capture of amino acids into protein. The investigators also want to test if 20 weeks resistance exercise training or drinking a cocktail of mixture of high flavanol cocoa (which can increase blood flow) and vitamin C can improve limb blood flow to older muscles and help reduce muscle wasting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

2.9 years

First QC Date

November 21, 2012

Last Update Submit

November 27, 2012

Conditions

Keywords

MicrovascularMuscleNutritionExerciseAgeing

Outcome Measures

Primary Outcomes (1)

  • Microvascular blood volume in response to feeding

    The final study participant was completed and all microvascular blood volume data analysed by August 2012. This outcome measure is applicable to all arms of this study and refers to responsiveness to a 2 hour feed protocol.

    September 2009 - August 2012

Secondary Outcomes (1)

  • Muscle protein metabolism in response to feeding

    January - October 2012

Other Outcomes (1)

  • Molecular pathways regulating muscle microvascular blood volume

    August 2012 - August 2013

Study Arms (5)

Young

NO INTERVENTION

Young subjects to be controlled to older individuals with interventions

Old

NO INTERVENTION

Older individuals to compare to young and other older intervention groups

Old Exercise

EXPERIMENTAL

Older individuals studied after an intervention of 20 weeks fully-supervised resistance exercise training

Behavioral: Old Exercise

Old Acute Cocoa

EXPERIMENTAL

Older individuals studied with the addition of cocoa flavanols during their acute study

Dietary Supplement: Old Acute Cocoa

Old 7 Day Cocoa

EXPERIMENTAL

Older individuals studied after 7 day supplementation of cocoa flavanols

Dietary Supplement: Old 7 Day Cocoa

Interventions

Old ExerciseBEHAVIORAL
Old Exercise
Old Acute CocoaDIETARY_SUPPLEMENT
Old Acute Cocoa
Old 7 Day CocoaDIETARY_SUPPLEMENT
Old 7 Day Cocoa

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers aged 18-28 or 65-75

You may not qualify if:

  • Overt muscle wasting i.e. muscle mass is more than 1 standard deviation below normal muscle or FFM for age
  • A BMI \< 24 or \> 28 kg•m2.
  • Active cardiovascular disease: uncontrolled hypertension (BP \> 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event
  • Individuals taking beta-adrenergic blocking agents.
  • Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial).
  • Respiratory disease including pulmonary hypertension, COPD, asthma or an FEV1 less than 1.5 l.
  • Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes.
  • Active inflammatory bowel disease, or renal disease,
  • Malignancy
  • Recent steroid treatment (within 6 mo), or hormone replacement therapy.
  • Clotting dysfunction
  • Musculoskeletal or neurological disorders.
  • Family history of early (\<55y) death from cardiovascular disease
  • Known sensitivity to Definity or methacholine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Physiology Laboratory, Graduate Entry Medical School, University of Nottingham, Royal Derby Hospital

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

Related Publications (1)

  • Phillips B, Williams J, Atherton P, Smith K, Hildebrandt W, Rankin D, Greenhaff P, Macdonald I, Rennie MJ. Resistance exercise training improves age-related declines in leg vascular conductance and rejuvenates acute leg blood flow responses to feeding and exercise. J Appl Physiol (1985). 2012 Feb;112(3):347-53. doi: 10.1152/japplphysiol.01031.2011. Epub 2011 Oct 13.

    PMID: 21998269BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • John P Williams, PhD, MD

    University of Nottingham

    PRINCIPAL INVESTIGATOR
  • Bethan E Phillips, PhD

    University of Nottingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

September 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations